Photocure ASA

Regulatory Filings • Oct 2, 2015

Photocure: First patient enrolled in Hexvix®/Cysview® Phase 3 Market Expansion Study

Photocure: First patient enrolled in Hexvix®/Cysview® Phase 3 Market Expansion Study

Oslo, Norway, October 2, 2015: Photocure (OSE: PHO), a specialty pharmaceutical

company focused on photodynamic technologies in cancer and dermatology, today

announces that the first patient has been enrolled in the Hexvix/Cysview Market

Expansion Phase 3 study. The study will investigate the use of Hexvix/Cysview in

the outpatient / surveillance setting and is designed to fulfill the FDA post

marketing commitments. Results from the Phase 3 study are expected to be

available in 2017.

The study is a prospective, multicenter Phase 3 study comparing the detection

and potential positive impact on patient management of bladder cancer in the

outpatient setting with Hexvix/Cysview using Blue Light enabled flexible

cystoscopy versus white light flexible cystoscopy. Eighteen top rated cancer

hospitals in the USA will participate in the study, which is planned to enroll

approximately 360 patients with non-muscle invasive bladder cancer.

There are approximately 1.2 million flexible cystoscopy procedures conducted on

a yearly basis in the United States. The use of Blue Light Flexible Cystoscopy

with Hexvix/Cysview in the outpatient / surveillance setting could allow

Urologists to detect recurrences at an earlier stage, which is of great clinical

benefit. Furthermore, as has been demonstrated with the current use of

Hexvix/Cysview during bladder cancer resection with blue light rigid

cystoscopes, the addition of Hexvix/Cysview in the surveillance of bladder

cancer patients may lead to better and earlier patient management decisions

resulting in improved clinical outcomes and health economic savings.

Dr. Raj Pruthi, Professor and Chair, Department of Urology, University of North

Carolina, Chapel Hill said: "The positive benefits of Hexvix/Cysview are well

documented in numerous trials for patients undergoing bladder cancer resections

during cystoscopy examination in the operating room. We are looking forward to

conducting the study with Blue Light Flexible Cystoscopy with Hexvix/Cysview to

confirm the benefits of this technology also in the outpatient setting. Early

detection of more lesions is expected to result in better treatment decisions as

well as more appropriate referrals and follow-up regimens, which in turn will

reduce the burden on patients and the health care system."

Kjetil Hestdal, President & CEO said: "This is an important milestone for

Photocure as we seek to expand the use of Hexvix/Cysview into the bladder cancer

surveillance market. Enabling Blue Light flexible cystoscopy with Hexvix/Cysview

in the surveillance setting will allow patients with non-muscle invasive bladder

cancer access to optimal treatment earlier, resulting in improved long-term

benefits for these patients. While this trial is ongoing in the USA, we will be

obtaining additional clinical and health economic data in EU from the use of

Hexvix/Cysview in the same setting in order to optimize best clinical practices

and patient outcomes."

For more information about the clinical trial:

https://clinicaltrials.gov/ct2/show/NCT02560584

For further information, please contact:

Photocure

President & CEO Kjetil Hestdal

Tel: + 47 913 19 535, Email: kh@photocure.no

CFO Erik Dahl

Tel: +47 450 55 000, Email: ed@photocure.no

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical

company and world leader in photodynamic technology. Based on our unique

proprietary Photocure Technology(®) platform, Photocure develops and

commercializes highly selective and effective solutions in disease areas with

high unmet medical need, such as bladder cancer, HPV and precancerous cervical

lesions, colorectal cancer and skin conditions. Our aim is to provide solutions

that can improve health outcomes for patients worldwide. Photocure is listed on

the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at

www.photocure.com.

About Hexvix(®)/Cysview(®)

Hexvix(®)/Cysview(®) (hexaminolevulinate hydro-chloride) is an innovative

breakthrough technology in the diagnosis and management of non-muscle-invasive

bladder cancer. It is designed to selectively target malignant cells in the

bladder and induce fluorescence during a cystoscopic procedure using a blue-

light enabled cystoscope. Using Hexvix(®)/Cysview(®) as an adjunct to standard

white-light cystoscopy enables the urologist to better detect and remove

lesions, leading to a reduced risk of recurrence. Hexvix(®)/Cysview(®) is

approved in Europe, Canada and the USA.

This information is subject of the disclosure requirements acc. to §5-12 vphl

(Norwegian Securities Trading Act)

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